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IRCT20230222057489N1 IRCT 2023-02-28 Oroumia University of Medical Sciences Assessment of the thiamine effect on post-operative delirium occurrence in patients undergoing hip surgery in intensive care unit Assessment of the thiamine effect on post-operative delirium occurrence in patients undergoing hip surgery in intensive care unit 2022-09-22 anticipated 55 Complete https://irct.ir/trial/68749 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling will be done by the random permutation block design method of two treatments with 5 blocks. First, 5 blocks of the composition (ABABA) will be listed and a code will be assigned to each, then according to the sample size equal to 55, 11 blocks will be selected in this order that the letter A for the group Thiamine and letter B will be considered for the control group receiving placebo. Patients will be randomly assigned to two groups A and B using Random Allocation computer software. By selecting the simple randomization method in the randomization method section and entering the total sample size determined in this software, numbers will be given to the patients and the patients will be entered into two groups based on the numbers given by the computer. Randomization will be done based on the permuted block randomization method. Each block will have 5 capacities. Based on the example of ABABA, in each block, people are evenly assigned to two groups. 11 blocks will be built. After that, in each block, people are randomly assigned to the thiamine group (55 people) or the placebo control group (B) (55 people). In this study, randomization will be simple, in a box the numbers 1 to 55 will be written on sheets of paper and placed inside the box in an unspecified manner. One sheet will be removed for each disease, if the number is even. It will be placed in the first group, and if it is an odd number, it will be in the second group, Blinding description: All the codes are secret and the examiner will be a doctor outside the research team responsible for delirium evaluation and they will not be informed about the grouping of people. Both the patients are unaware of the delirium group they are in, and the doctor responsible for delirium assessment will not know the patient group. A placebo with the same color and appearance as thiamine will be prepared and assigned by the pharmaceutical department. Finally, after collecting the data of each group separately, they will be compared by the evaluator doctor who does not know about the patient group. The primary outcome of the study will be the incidence of delirium after surgery. 1-2 delirium. Intervention 1: Intervention group: Intervention of a 300 mg oral thiamine tablet daily for 3 days. Intervention 2: Control group: One 300 mg placebo tablet for 3 days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Based on the results of the study
public Mohammad Amin Valizad Hasanlui
Emam khomini university hospital-Eeshad AVE-Modarres Blvd-urmia-iran
Urmia Iran (Islamic Republic of) 5715781351 +98 44 3346 9931 aminvalizade@yahoo.com Oroumia University of Medical Sciences scientific Mohammad Amin Valizad Hasanlui
Emam khomini university hospital-Eeshad AVE-Modarres Blvd-urmia-iran
Urmia Iran (Islamic Republic of) 5715781351 +98 44 3346 9931 aminvalizade@yahoo.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Patients over 60 years old after hip surgery Hospitalization in the intensive care unit 60 years no limit Both Patients with a history of mental disorder Severe renal failure Severe liver failure Drug or alcohol abuse Diabetic ketoacidosis History of delirium F05 Delirium due to known physiological condition Treatment - Drugs Placebo Intervention group: Intervention of a 300 mg oral thiamine tablet daily for 3 days Control group: One 300 mg placebo tablet for 3 days The effects of thiamine to prevent delirium. Timepoint: 76 / 5,000Translation resultsTranslation resultHip surgery patients over the age of 60 were hospitalized in the intensive care unit for 3 days. Method of measurement: First, changes in the level of consciousness in the intensive care unit will be evaluated based on the Richmond restlessness-calmness scale. The degree of restlessness will be divided from 0 to 4. In unconscious patients, the level of sedation will be scored based on the duration of eye contact (-1 to -3). Patients without opening their eyes following verbal stimulation (recorded as -4 to -5) will not be included in the study (45). CAM-ICU includes four characteristics: (1) change in mental status from the beginning, (2) inattention, (3) disturbed thinking, and (4) change in level of consciousness. If the patient is positive for both features 1 and 2 and any feature 3 or 4, delirium will be diagnosed. During the study period, sedation and delirium will be evaluated for each patient every 12 hours. Fentanyl narcotic will be used for patients for post-operative analgesia. If any of the patients develop delirium, haloperidol 5 mg intramuscularly will be used. Any new episode, flushing, itching, diaphoresis, nausea, and phonic edema during the study period will be considered as side effects of thiamine drugs. Oroumia University of Medical Sciences Approved 2022-08-29 Ethics Committee of Urmia University of Medical Sciences Emam khomini university hospital-Eeshad AVE-Modarres Blvd-urmia-iran Urmia West Azarbaijan Iran (Islamic Republic of)